Blood collection container

ABSTRACT

A container for housing body fluids, preferably blood in its component form. The container comprises a body defined by flexible walls having an interior for housing the body fluid. Additionally, a means for allowing selective fluid flow allows the blood components to be expressed from one chamber of the container into another to separate and separately house the blood components. The present invention also provides a method for separating blood into its components and individually storing same.

This appication is a continuation of U.S. patent application Ser. No.08/241,080, filed May 11, 1994, now abandoned.

BACKGROUND OF THE INVENTION

The present invention generally relates to the storage of body fluids.More specifically, the present invention relates to the separation ofblood into its components and the storage of blood components.

It is, of course, known to use blood and other body fluids in a numberof medical procedures. Blood transfusions are an example of suchprocedures. Blood is collected from a donor and can be transfused into arecipient.

Blood after being received from a donor is stored, typically, inflexible plastic containers until use. Blood can either be stored in acontainer as whole blood or broken down into its individual components,(i.e., plasma, buffy coat layer, and packed red cells). For example, itis known to separate whole blood either through a centrifuge process, ora process such as that disclosed in U.S. Pat. Nos. 4,350,585 and4,608,178, into plasma, buffy coat, and packed red cells.

In a great majority of cases, blood is stored for a number of days andnot immediately infused into a recipient. In most situations, the bloodcomponents are separately stored. For example, it is known to separatelystore and utilize the red blood cell component of whole blood.

In order to maintain the viability of red blood cells and other bloodcomponents, it is necessary to provide a storage solution to provide anenergy source for the red blood cells.

Previous systems of manual blood collection consist of several bloodpacks connected with pieces of tubing and isolated, if necessary, byfrangible parts. Most of the prior art pack configurations have asimilar construction with a collection bag filled with anti-coagulantsolution wherein, e. g., one pack is dedicated to the storage of redblood cell concentrates mixed with the preservative solution and onetransfer pack is dedicated to the processing and storage of plasma.

In a known system, marketed by Baxter International under the trademarksOPTIPRESS® and OPTIPAC®, whole blood is collected. The whole blood isthen centrifuged to separate the blood into plasma, red blood cells, anda buffy coat. Plasma and red blood cells are separated by being removedfrom the blood pack through top and bottom tubes connected to peripheraltransfer packs.

Although, the use of a triple pack configuration provides a system thatcan store blood components, a typical triple blood pack can present someissues. For example, the handling of a triple blood pack can becumbersome due to the tubing becoming knotted and intertwined. Further,the pieces of tubing in the triple packs are labor intensive tomanufacture and can create problems with bonding and kinking duringsterilization. Furthermore, the packaging of triple packs with attachedtubing can be problematic.

There therefore may be a need for an improved system for collecting andstoring blood and its components.

SUMMARY OF THE INVENTION

The present invention provides an improved blood collection system. Tothis end, a single container is provided for separately housing bloodcomponents. The container includes a body defined by flexible wallsdefining at least a first, a second and a third chamber. Means areprovided for allowing selective fluid communication between the firstchamber and the second chamber and between the second chamber and thethird chamber. The container of the present invention provides a compacttubeless system for collecting and separately storing blood components.

In use, blood can be collected in the middle or second chamber of thecontainer. The container is then centrifuged to separate the blood intoa plasma layer, a red blood cell layer, and a buffy coat layer. Theupper layer will be the plasma layer, the middle layer the buffy coatlayer and the lower layer the red blood cell layer. Pursuant to thepresent invention, the frangible connections located in the tubesbetween the first and second chamber and second and third chamber, canbe separated and the bottom layer expressed into the first chamber andthe top layer expressed into the third chamber.

In an embodiment, a blood separator is used to express the blood intothe different chamber.

In an embodiment, the chambers are sealed by heat sealing the tubesafter the blood components are expressed into appropriate chambers.

In an embodiment, the blood collection system has bar code labeling foridentification.

In an embodiment, the present invention provides a blood separationapparatus having a means for sensing levels of blood and its components.In an embodiment, the blood separation apparatus has an optical sensor.

In an embodiment, the container has a plurality of mounting holes forsecuring the container to the blood separation apparatus.

An advantage of the present invention is that it provides an improvedcontainer for housing blood components.

Another advantage of the present invention is that it provides a bloodcollection system that reduces the manufacturing costs by providing thecapability for high volume, highly automated production.

Moreover, an advantage of the present invention is that it provides animproved method for storing blood components.

Further, an advantage of the present invention is that it provides ablood collection system having improved handling characteristics.

Still further, an advantage of the present invention is that it providesa blood collection system that does not include a plurality of tubing.

Another advantage of the present invention is that it provides severalchannels of separated blood for later analysis. Moreover, an advantageof the present invention is that it provides a blood collection systemwith improved labeling features for better traceability and safety.

Another advantage of the present invention is to provide an apparatusfor improved blood separation.

Additional features and advantages of the present invention aredescribed in, and will be apparent from, the detailed description of thepresently preferred embodiments and from the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of a container of the presentinvention.

FIG. 2 illustrates the container of the present invention of FIG. 1 in apreferred folded orientation in preparation for centrifugation.

FIG. 3 illustrates an embodiment of the container of the presentinvention mounted in a blood separation system.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

The present invention provides an apparatus and method for separatingand storing blood components in separate chambers. As used herein, theterm "blood" includes whole blood as well as its components including,but not limited to, red blood cells, plasma, platelets, and leukocytes(i.e., buffy coat).

Pursuant to the present invention, an integral container is provided forcollecting, separating, and storing blood components. Referring now tothe figures, FIG. 1 illustrates the blood collection system of thepresent invention. Preferably the container includes a body made offlexible material (i.e., PVC or other suitable material). The body isdivided into multiple chambers that can house blood and separately storethe blood components in the individual chambers. The chambers are alsoisolated by frangible access ports.

Referring specifically to an embodiment illustrated in FIG. 1, acontainer 10 having a body 12 is preferably constructed from flexiblesheets of plastic. The sheets are sealed along their edges 14 to createan interior 15. The container 10 is divided into three chambers, namely,a first chamber 17, a second chamber 18 and a third chamber 19.

A number of plastics can be utilized. Depending on the specificcomponents to be stored, certain plastics may be more desirable. In anembodiment, the container is constructed from a polyvinyl chloridematerial that is plasticized and includes stabilizers. The containermaterial is preferably flexible to facilitate folding the container forstorage. To this end, a fold line 13 is provided between each chamber ofthe container to facilitate folding the container for centrifuging andother processing while the blood is stored in the container.

Each chamber of the container 10 preferably includes at least one portthat provides access to the interior 15 of the individual chambers. Forexample, a donor tube 20 is provided, through which blood can becollected into the second chamber 18 of the container. In the preferredembodiment illustrated, sterile connections sites 22 and administrationports 21 are also provided on each chamber of the container.

In order to provide means for allowing the blood components to be storedin separate compartments, at least two tube members are provided. Afirst tube member 28 being located between the first and second chambers17 and 18, respectively, and a tube 29 being located between the secondand third chambers 18 and 19, respectively. In order to provideselective fluid flow between the chambers, a frangible cannula 30 and 31is located in each of the tubes 28 and 29, respectively. By breaking theappropriate frangible cannula, fluid flow between the chambers can beestablished. Of course, other means of establishing selective fluidcommunication can be used.

In the illustrated embodiment, another feature provided on each chamberof the container and illustrated in FIG. 1 is means (mounting holes) forsecuring the container 10 to a blood separator 50 (discussed below). Inthe illustrated embodiment, the mounting holes 41 are locatedapproximately at the outer edges of the first chamber 17 and the thirdchamber 19. Additionally, the center chamber 18 has two sets of mountingholes 41. The mounting holes 41 are used to align the container 10 on ablood separator 50 (discussed below).

Another illustrated feature of the container is a set of segmentssealing lines 40. These are located, for example, on the edge of thefirst chamber 17 and can be used for providing cross-matching segments.In addition to providing cross-matching segments, which aid in theidentification of the blood components, the present inventionadvantageously provides a further identification feature, namely adonation number identifying each chamber with a bar code 61 or a numberprinted on the pack during manufacturing. This bar code 61 provides thatthe three individual packs are identifiably correlated.

Also illustrated in FIG. 1 are peelable stickers 62 with correspondingdonation numbers. These stickers 62 provide labeling for the individualchambers that house the blood components and can be printed and affixedto the chambers during the manufacturing of the container. The peelablestickers 62 also provide that the three individual packs areidentifiably correlated, i.e. as being from the same source. Also, thepeelable stickers 62 provide for other specialized labeling functions asdesired. For example, these stickers 62 provide labeling for later useon test tubes containing the donor's blood samples.

Many of the features of the preferred embodiments listed above improveand facilitate a primary purpose of the present invention, to wit, thecollection, separation and storage of blood. In a preferred embodimentof the present invention, the blood is collected from the patient andenters the center or second chamber 18 of the three-chambered pack 10.To accomplish this, the donor tube 20 extends either from a donor needleor from another container containing blood. Blood then flows through thedonor tube 20 into the interior 15 of the container 10. Each of thechambers is provided with an administration port 21 and a sterileconnection site 22 to process the contents of the component packs byusual blood bank procedures (i.e., red cell filtration on SAG-M pack,buffy coat pooling and single donor platelet by a known PRP method).After donation is completed, the donor tube 20 is stripped and sealed toprovide cross-matching segments, if necessary.

Also, after the blood has been added to the container 10 pursuant to theinvention, the donor tube 20 can be severed from the container 10. Avariety of methods can be used to so sever the donor tube 20 includingusing a heat sealer. The donor tube 20 can then be used forcross-matching purposes.

After collecting the blood, further processing can be performed, i.e.,centrifugation for separating the blood into its components. To thisend, the pack is folded as shown in FIG. 2 in preparation forcentrifugation. First, the first chamber 17 is laid flat. Then thesecond chamber 18 is folded upon it along the fold line 13 between theadjacent first and second chambers. Finally, the third chamber 19 issimilarly folded upon the second chamber 18 along the fold line 13between the adjacent second and third chambers. The folded pack providesa clean, efficient package for easily handling the collected blood; noexcessive tubing is present to become tangled. The folded pack is thenplaced in a centrifuge bucket for spinning with the sterile connectionsites 22 and administrative ports 21 placed on the side of the assembly.

The centrifuge separates the collected whole blood into its components(i.e., plasma, buffy coat layer and packed red cells). The separatedlayers are all contained within the second chamber 18 aftercentrifugation; the components are stratified. The packed red cellsreside nearest the fold line 13 at the junction of the first chamber 17and the second chamber 18. The plasma resides nearest the fold line 13at the junction of the second chamber 18 and the third chamber 19. Thebuffy coat is disposed between the red cells and plasma in the secondchamber 18.

After centrifugation to separate the three components of the donatedblood (i.e., plasma, buffy coat layer, and packed red cells), thecollection system is carefully unfolded and secured to a blood componentseparator. The blood component separator preferably operates in a mannersimilar to that used in a press sold by affiliates of BaxterInternational under the trademark OPTIPRESS®.

FIG. 3 is an embodiment of the invention illustrating a blood componentseparator apparatus 50 that can be used for separating whole blood intoplasma, red blood cells, and buffy coat.

A preferred embodiment illustrated in FIG. 3 provides an automated bloodcomponent separator 50. The separator 50 has a front face 55 and acontrol panel 56. The operator uses this panel 56 to operate the bloodcomponent separator 50 in an automated manner. Thus, after the bloodcomponent separator 50 has been activated, the operator may leave theautomated separator 50 unattended to separate the collected whole bloodinto its components. To accomplish this, the container 10 is secured tothe front face 55 of the blood component separator 50 by using mountingpegs 52 which cooperate with the alignment mounting holes 41 on thecontainer 10. Also shown in FIG. 3 near the base of the separator 50 isa segment sealing bar 51, which aids in holding the container 10 to theblood component separator 50.

Further elements of the blood component separator 50 include a frangibleopening, sealing and cutting bar 54. This bar 54 is located at thefolding seam 13 between the first chamber 17 and the second chamber 18,approximately a third of the way up the front face 55. Similarly, at thefolding seam 13 between the second chamber 18 and the third chamber 19is another similar bar 54. In addition, the frangible opening, sealingand cutting bar 54 has tools for accomplishing several tasks. Forexample, the bar 54 has a tool for opening the frangible cannula 30 toprovide fluid communication between the adjacent chambers. These bars 54also aid in holding the container 10.

In the preferred embodiment illustrated, in order to provide selectivefluid communication between the interior 15 of one chamber and theinterior 15 of another chamber of the container 10, a frangible cannula30 is utilized. To provide fluid communication, the frangible cannula 30is biased so that a portion thereof breaks away from the remainingportions of the cannula. This allows the fluid within one chamber toflow into the interior of an adjacent chamber of the container, forexample, from the second chamber 18 to the first chamber 17. Although inthe embodiment illustrated, a frangible cannula 30 is used, any meansfor allowing selective access between the interiors of the container canbe utilized.

To this end, the frangible opening, sealing and cutting bars 54 locatedat the top and bottom of the center or second chamber 18 have toolsdesigned to open the frangible cannula 30, 31 to allow fluid flowbetween the peripheral chambers. By using the frangible opening bar 54to open the frangible cannula 30, fluid communication between, forexample, the first chamber 17 and the second chamber 18 can occur.

With the centrifuged container 10, having the stratified layers of bloodcomponents (i.e., an upper layer of blood plasma, a center layer ofbuffy coat and a lower layer of red blood cells) in the center or secondchamber 18, secured to the blood separator 50, the separation of thecomponents into separate chambers may begin. The bars 54 open thecannula 30 and 31 to allow fluid communication from the second chamber18 to the first chamber 17 and from the second chamber 18 to the thirdchamber 19, respectively.

The blood separator 50 is provided with appropriate means for expressingthe upper plasma layer from the center or second chamber 18 through theupper cannula 31 to the empty upper or third chamber 19. Similarly, theblood separator 50 is provided with appropriate means for expressing thelower red blood cell layer from the center or second chamber 18 throughthe lower cannula 30 to the lower or first chamber 17. The first chamber17 is prefilled with a preservative solution to permit extended storageof the red blood cells.

The top and bottom flows are controlled by clamps (not shown). Theclamps are monitored with the optical monitoring device 53 illustratedin FIG. 3. The optical monitoring device 53 detects the levels of theblood components in the chambers. This device detects when substantiallyall the red blood cells have been expressed from the second chamber 18to the first chamber 17. The optical monitoring device 53 thus activatesthe clamps to prevent further fluid flow. In addition, the flow ofplasma from the second chamber 18 to the third chamber 19 is expressedand stopped in a similar fashion. In this embodiment, only theappropriate blood components are expressed to the appropriate peripheralchambers. As a result of the expressing of the blood components, thesecond chamber 18 subsequently contains only the buffy coat layer. Thus,after the completed separation, the plasma is in the third chamber 19,the buffy coat is in the collection bag; i.e., the second chamber 18 andthe red blood cells are in the first chamber 17.

To this end, after the blood components transfer is completed, the topand bottom transfer channels (i.e., the tubes 28 and 29) are sealed bytools located in the same sealing and cutting bars 54. This preventsfurther fluid communication between the chambers.

The first and second chambers and the second and third chambers are thenseparated by cutting them away with a knife integrated into the sealingand cutting bars 54 or by tearing them by hand using a pre-notchedfolding line 13. Thus, after separation, each chamber becomes anindependent pack. The three separate chambers can then be distributed towhere they are needed or stored individually until required.

As shown in FIG. 1, and briefly discussed above, the container 10 haslabeling on each of the chambers. In a preferred embodiment, the labelis a bar code 61. The bar code is generated so that information foridentifying the source of the blood is readily available. Also, fortracking and safety concerns, the bar code 61 on each individual chamberpack is correlated. Thus, if one chamber pack is found to be unusablefor any reason, the other two separate chamber packs can be locatedsimply by examining the corresponding bar code and recalling the suspectchamber packs for inspection. This benefit is especially advantageousbecause of its simplicity. For instance, the bar code can be printed onthe three chambers individually while they are being manufactured andremain a part of a single, integral container. Thus, the possibility ofhuman error involved in applying separate labels to these individualseparated packs, as is done in present practice, is virtually nullified.

In a further embodiment, an additional processing step may be performedto aid in identification of the blood. The pre-notched cross-matchingsegments 40 shown on the first chamber 17 can be sealed by the segmentsealing bar 51. Cross-matching segments 40 can also be integrated in thepack design by isolating channels in the first chamber 17, the SAG-Mpack, for example as shown in FIG. 1. The channels in the first chamber17 are arranged parallel to each other at the outer edge. Also, thecross-matching segments 40 are pre-notched. Further, they could beisolated by using a tube sealer or by adding a sealing segment step onthe component separator. The channels could also have bar codes foridentification purposes.

Now referring again to FIG. 3 with the container 10 held on the bloodcomponent separator 50, the cross-matching segments 50 are disposed nearthe bottom of the front face 55. Three segments sealing bars 51 mountedto the front face 55 are disposed directly above and perpendicular tothe channels of the cross-matching segments 40. If desired, the segmentssealing bar 51 is used to seal the pre-notched segments 40. Then, thesealed segments are cut or torn apart along the notch lines. In thismanner, segments are created for cross-matching.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present invention andwithout diminishing its attendant advantages. It is therefore intendedthat such changes and modifications be covered by the appended claims.

We claim:
 1. A container for housing blood products comprising:anintegral body defined by flexible walls defining at least a first, asecond and a third chamber, the chambers linearly arranged in ahorizontal row with the first chamber adjoining the second chamber andthe second chamber adjoining the third chamber, each chamber having alinear exterior edge wherein the linear exterior edge of the firstchamber adjoins the linear exterior edge of the second chamber and thelinear exterior edge of the second chamber adjoins the linear exterioredge of the third chamber forming a linear side and further wherein aconnection site and an exterior port are located on each of the exterioredges; and means for allowing selective fluid communication between afirst chamber and a second chamber and between a second chamber and athird chamber.
 2. The container of claim 1 wherein the means forallowing selective fluid communication is a frangible access port. 3.The container of claim 1 wherein the body is constructed from plastic.4. The container of claim 1 wherein the body includes apertures forsecuring the body on blood processing equipment.
 5. The container ofclaim 1 wherein the body includes a flexible edge between each chamberconstructed so that the chambers can be folded upon each other at thechamber edge.
 6. The container of claim 1 further comprising a means forlabeling the container wherein each chamber bears similar indicia. 7.The container of claim 6 wherein said means for labeling is a bar code.8. The container of claim 1 wherein one of the chambers furthercomprises a wall member for defining at least one channel in fluidcommunication with the chamber.
 9. The container of claim 8 wherein thechannel is located in a portion of the container that includes a labelon one of the flexible walls that defines the portion.
 10. The containerof claim 9 wherein the label is a bar code.
 11. The container of claim 9wherein the label is a peelable sticker.
 12. A container for housingblood comprising:an integral body defining at least two interiorchambers for housing blood, each chamber having an exterior edge formedalong one side of each of the chambers forming a continuous edge of thebody and a common edge wherein the chambers are joined at the commonedge and further wherein each of the at least two interior chambersincludes a connection site and an exterior port located on the exterioredge; a port located through the common edge of the at least twochambers, the port including a frangible member in the port that uponbreakage allows fluid flow from one of the at least two chambers of thebody to another one of the at least two chambers; and a tube allowingblood to be received in one of the at least two chambers.
 13. Thecontainer of claim 12 wherein the body is constructed from plastic. 14.The container of claim 12 wherein the body is constructed from apolyvinyl chloride-containing material.
 15. The container of claim 12wherein the body includes three chambers.